TRYNGOLZA olezarsen sodium 80 mg/.8mL Injection, Solution, 1 syringe — NDC 71860-101-01 (Billing 71860-0101-01)
This is a package of 1 syringe of TRYNGOLZA olezarsen sodium 80 mg/.8mL Injection, Solution from Ionis Pharmaceuticals, Inc., marketed since Dec 2024 and currently FDA-listed. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 71860-101-01 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 71860 labeler · 101 product · 01 package
- Package marketed since
- Dec 19, 2024
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2027
- Barcode (UPC-A, from the NDC)
- 3 7186010101 6
- Medicaid fills, this package
- 178 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 086954
- GCN: 56759
- GPI-14 (Medi-Span): 3090626530D540
- HICL (First Databank): 050111
- AHFS class code: 24:06.92.00
- RxCUI (RxNorm): 2701422
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
Clinical
Olezarsen Injection is used lower triglycerides (fat) in the blood in patients with familial heterozygous hypercholesterolemia (HeFH) (an inherited condition in which cholesterol cannot be removed from the body normally) and to lower the risk of pancreatitis (inflammation of the pancreas) in patients with high triglyceride levels. Olezarsen is in a class of medications called apolipoprotein C-III inhibitors. It works by decreasing the production of apoC-III, which increases the breakdown and removal of triglyercerides from the body.
Read the full MedlinePlus article ↗Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $62,276.27 | $49,821.01 / 0.8 ml |
| Medicare drug plans payPart D · Q2 2026 | $4,214.86 | $3,371.89 / 0.8 ml |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 71860-0101-01 You're viewing this Main listing | 1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS | 2024-12-19 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Tryngolza 80 mg/.8mLthis 71860-0101-01 | Ionis | 1 syringe | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 12509684 ↗ | Method of use | U-4050 | May 1, 2034 |
| US 9593333 ↗ | Method of use | U-4050 | Feb 14, 2034 |
| US 9157082 ↗ | Method of use | U-4050 | Apr 27, 2032 |
| US 12509684 ↗ | Method of use | U-4580 | May 1, 2034 |
| US 9157082 ↗ | Method of use | U-4580 | Apr 27, 2032 |
| US 9157082 ↗ | Method of use | U-4580 | Apr 27, 2032 |
| US 12509684 ↗ | Method of use | U-4580 | May 1, 2034 |
| US 9181549 ↗ | Drug substance | — | May 1, 2034 |
| US 9181549 ↗ | Drug substance | — | May 1, 2034 |
| US 9163239 ↗ | Drug substance | — | May 1, 2034 |
| US 9127276 ↗ | Drug substance | — | May 1, 2034 |
| US 9127276 ↗ | Drug substance | — | May 1, 2034 |
| US 9163239 ↗ | Drug substance | — | May 1, 2034 |
| Code | What it grants | Expires |
|---|---|---|
| I-992 | New indication (3-year) | Jun 24, 2029 |
| ODE-515 | Orphan Drug Exclusivity (7-year) | Dec 19, 2031 |
| NS | New Strength | Jun 24, 2029 |
Is there a generic version of TRYNGOLZA 80 MG/0.8 ML AUTOINJ?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII QTT17582CB
A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 22ADO53M6F
A mineral salt derived from phosphoric acid, used as a buffer to maintain the pH balance of the medication and help stabilize the active ingredients.
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UNII 3980JIH2SW
A salt form of phosphoric acid that acts as a buffer and pH adjuster in medicines. It helps keep the product at the correct acidity level for stability and effectiveness.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Ionis Pharmaceuticals, Inc. labeler code 71860
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE TRYNGOLZA ® is indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS). To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). TRYNGOLZA is an apolipoprotein C-III (apoC-III)-directed antisense oligonucleotide (ASO) indicated as an adjunct to diet: To reduce triglycerides (TG) in adults with familial chylomicronemia syndrome (FCS).
( 1 ) To reduce TG and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (sHTG: TG greater than or equal to 500 mg/dL). ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Adults with FCS: The recommended dosage of TRYNGOLZA is 80 mg injected subcutaneously once monthly. ( 2.1 ) Adults with sHTG: The recommended dosage of TRYNGOLZA is 50 mg injected subcutaneously once monthly. For patients with sHTG who tolerate the 50 mg dosage and additional TG reduction is clinically indicated, the dosage may be increased to 80 mg injected subcutaneously once monthly.
( 2.1 ) Inject TRYNGOLZA subcutaneously into the abdomen or front of the thigh. The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection. ( 2.2 )
2.1Recommended Dosage In adults with FCS: The recommended dosage of TRYNGOLZA is 80 mg injected subcutaneously once monthly [see Dosage and Administration (2.2) ] . In adults with sHTG: The recommended dosage of TRYNGOLZA is 50 mg injected subcutaneously once monthly [see Dosage and Administration (2.2) ]. Assess TG when clinically appropriate.
The TG-lowering effect of TRYNGOLZA may be measured within 3 months after initiation. For patients who tolerate the 50 mg dosage and additional TG reduction is clinically indicated, the dosage may be increased to 80 mg injected subcutaneously once monthly.
2.2Administration Instructions Prior to initiation, train patients and/or caregivers on proper preparation and administration of TRYNGOLZA [see Instructions for Use ] . Advise patients to maintain a low-fat diet in conjunction with TRYNGOLZA. Instruct patients with FCS to consume 20 g or less of fat per day.
Remove the single-dose autoinjector from the refrigerator and let the autoinjector come to room temperature 30 minutes prior to the injection. Do not use other warming methods. Inspect TRYNGOLZA visually for particulate matter prior to administration.
The solution should be a clear and colorless to yellow liquid. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration. Inject TRYNGOLZA subcutaneously into the abdomen or front of the thigh.
The back of the upper arm can also be used as an injection site if a healthcare provider or caregiver administers the injection. Administer TRYNGOLZA as soon as possible after a missed dose. Resume dosing at monthly intervals from the date of the most recently administered dose.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 50 mg/0.8 mL of olezarsen as a clear, colorless to yellow solution in a single-dose autoinjector 80 mg/0.8 mL of olezarsen as a clear, colorless to yellow solution in a single-dose autoinjector Injection: 50 mg/0.8 mL in a single-dose autoinjector. ( 3 ) 80 mg/0.8 mL in a single-dose autoinjector. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA. Hypersensitivity reactions, including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias, requiring medical treatment have occurred [see Warnings and Precautions (5.1) ] . History of serious hypersensitivity reactions to olezarsen or any of the excipients in TRYNGOLZA.
( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. ( 5.1 ) Liver Enzyme Abnormalities: Increases in liver enzymes and hepatic fat have occurred in adults.
Consider liver enzyme testing before TRYNGOLZA initiation or an increase in dosage and when clinically indicated thereafter. If persistent elevations in liver enzymes occur, consider dose interruption and/or dose reduction. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue TRYNGOLZA.
( 5.2 )
5.1Hypersensitivity Reactions Hypersensitivity reactions (including symptoms of bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias) have been reported in patients treated with TRYNGOLZA [see Adverse Reactions (6.1) ] . Advise patients on the signs and symptoms of hypersensitivity reactions and instruct patients to promptly seek medical attention and discontinue use of TRYNGOLZA if hypersensitivity reactions occur. TRYNGOLZA is contraindicated in patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
5.2Liver Enzyme Abnormalities TRYNGOLZA can cause increases in liver enzymes and hepatic fat in adults [see Adverse Reactions (6.1) ] . Increases in liver enzymes were more frequently reported with the 80 mg dose as compared to the 50 mg dose. In patients with sHTG, increases in liver enzymes greater than or equal to three times the upper limit of normal were reported more frequently with TRYNGOLZA 80 mg (7%) compared to TRYNGOLZA 50 mg (3%) and placebo (3%).
Consider liver enzyme testing before TRYNGOLZA initiation or an increase in dosage and when clinically indicated thereafter. If persistent elevations in liver enzymes occur (such as three times the upper limit of normal or greater), consider dose interruption and/or dose reduction. If serious hepatic injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs, promptly discontinue TRYNGOLZA.
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Hypersensitivity Reactions [ see Warnings and Precautions (5.1) ] Liver Enzyme Abnormalities [see Warnings and Precautions (5.2) ] Most common adverse reactions in patients with FCS (incidence >5% of TRYNGOLZA-treated patients and >3% higher frequency than placebo) were injection site reactions, decreased platelet count, and arthralgia. ( 6.1 ) Most common adverse reactions in patients with sHTG (incidence ≥2% higher than placebo) were injection site reactions and liver enzyme increases.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ionis Pharmaceuticals, Inc. at toll free number 1-833-644-6647 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of TRYNGOLZA cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial in Patients with FCS The safety of TRYNGOLZA was evaluated in 66 patients with FCS enrolled in Trial 1 (NCT #04568434) [see Clinical Studies (14.1) ] . In this trial, 43 patients received at least one dose of TRYNGOLZA, 50 mg (N=21) or 80 mg (N=22) and 23 patients received placebo.
TRYNGOLZA 50 mg is not an approved dosing regimen for FCS [see Dosage and Administration (2.1) ]. Across treatment groups, the mean age was 45 years and 42% of patients were male. Eighty-five percent (85%) of patients were White, 9% were Asian and 6% were reported as other races; 11% identified as Hispanic or Latino ethnicity.
Forty-three (43) patients were exposed to TRYNGOLZA for a median of 52 weeks; 22 patients were treated with TRYNGOLZA 80 mg every 4 weeks for a median of 52 weeks. Adverse reactions led to discontinuation of treatment in 7% of TRYNGOLZA-treated patients and 0% of placebo-treated patients. The most common reason for TRYNGOLZA treatment discontinuation was hypersensitivity reactions.
Adverse reactions (>5% of patients treated with TRYNGOLZA and at >3% higher frequency than placebo) are presented in Table 1. Table 1. Adverse Reactions That Occurred in >5% of Patients with FCS Treated with TRYNGOLZA and at >3% Higher Frequency than with Placebo (Trial 1) Adverse Reaction Grouped terms composed of several similar terms Total TRYNGOLZA (N=43) Placebo (N=23) Injection site reactions 8 (19%) 2 (9%) Decreased platelet count 5 (12%) 1 (4%) Arthralgia 4 (9%) 0 Clinical Trials in Patients with sHTG The safety of TRYNGOLZA was evaluated in two randomized, double-blind, placebo-controlled trials [Trial 2 (NCT #05079919) and Trial 3 (NCT #05552326)] that included a total of 1,061 adult patients with sHTG [see Clinical Studies (14.2) ] .
In these trials, 705 patients received at least one dose of TRYNGOLZA, 50 mg (N=354) or 80 mg (N=351), and 356 patients received placebo. Across treatment groups, the mean age was 54 years and 76% of patients were male. Eighty-eight percent (88%) of patients were White, 5% Asian, 2% Black or African American, 2% American Indian or Alaskan Native, less than 1% Native Hawaiian or Pacific Islander, and 2% other or multiple races; 12% identified as Hispanic or Latino ethnicity.
The median exposure to TRYNGOLZA was 364 days (N=705). Adverse reactions led to discontinuation of treatment in 5% of TRYNGOLZA-treated patients and 2% of placebo-treated patients. The most common adverse reaction for TRYNGOLZA treatment discontinuation was injection site reactions.
Adverse reactions (in patients treated with TRYNGOLZA at ≥2% higher frequency than placebo) are presented in Table 2. Table 2. Adverse Reactions Occurring in ≥2% of Patients with sHTG Treated with TRYNGOLZA than with Placebo (Trial 2 and Trial 3) Adverse Reaction Grouped terms composed of several similar terms TRYNGOLZA 50 mg (N=354) TRYNGOLZA 80 mg (N=351) Placebo (N=356) Injection site rea… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data on TRYNGOLZA use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS or sHTG are at risk for pancreatitis during pregnancy because of increased TG levels (see Clinical Considerations ) . In animal reproduction studies conducted with the unconjugated antisense oligonucleotide (lacking N -acetylgalactosamine [GalNAc]) in rabbits and mice, no adverse effects on development or pregnancy were observed at doses 21 times or 20 times, respectively, the maximum recommended clinical dose.
The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Triglyceride levels increase during the third trimester of pregnancy. In patients with underlying defects in triglyceride metabolism, severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy. Data Animal Data Olezarsen was not evaluated for potential effects on embryofetal development (EFD).
However, effects of the administration of the unconjugated antisense oligonucleotide (ASO), which shares the same nucleotide sequence but lacks the (GalNAc) moiety [see Description (11) ] , were evaluated. In a combined fertility and embryo-fetal development study in mice, the unconjugated ASO was administered to male and female mice by subcutaneous injection at doses of 10.5, 35, and 87.5 mg/kg/week prior to mating and through to the completion of organogenesis (gestation day 15). No adverse developmental outcomes occurred at doses up to 87.5 mg/kg/week (approximately 21-times the monthly maximum recommended human dose (MRHD) based on a body surface area (BSA) comparison of the unconjugated ASO).
In an embryo-fetal development study in pregnant rabbits, the unconjugated ASO was administered by subcutaneous injection at doses of 10.5, 21, and 52.5 mg/kg/week during the period of organogenesis (gestation days 6 to 18). No adverse developmental effects were observed at doses up to 21 mg/kg/week (approximately 20-times the monthly MRHD based on a BSA comparison of the unconjugated ASO). In a pre-/postnatal toxicity study in mice, the unconjugated ASO was administered at 10.5, 35, or 87.5 mg/kg/week during the period of organogenesis and continuing until weaning (gestation day 6 through lactation day 21).
Offspring body weights at 87.5 mg/kg/week (21-times the monthly MRHD based on BSA) were lower throughout their lives and were associated with slight delays in the attainment of morphological and developmental landmarks. No adverse effects on offspring were observed at 35 mg/kg/week (approximately 9-times the monthly MRHD based on a BSA comparison of the unconjugated ASO).
8.2Lactation Risk Summary There are no data on the presence of olezarsen in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. However, the unconjugated antisense ASO, which shares the same nucleotide sequence but lacks GalNAc, was present in the milk of lactating mice at low levels. When a drug is present in animal milk, it is likely that the drug will be present in human milk.
Oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered unlikely that low levels present in milk will lead to clinically relevant levels in breastfed infants. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TRYNGOLZA and any potential adverse effects on the breastfed infant from TRYNGOLZA or from the underl… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data on TRYNGOLZA use in pregnant women to inform drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Patients with FCS or sHTG are at risk for pancreatitis during pregnancy because of increased TG levels (see Clinical Considerations ) . In animal reproduction studies conducted with the unconjugated antisense oligonucleotide (lacking N -acetylgalactosamine [GalNAc]) in rabbits and mice, no adverse effects on development or pregnancy were observed at doses 21 times or 20 times, respectively, the maximum recommended clinical dose.
The background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
Clinical Considerations Disease-Associated Maternal and/or Embryo-Fetal Risk Triglyceride levels increase during the third trimester of pregnancy. In patients with underlying defects in triglyceride metabolism, severe gestational hypertriglyceridemia may occur, increasing the risk of acute pancreatitis during pregnancy. Data Animal Data Olezarsen was not evaluated for potential effects on embryofetal development (EFD).
However, effects of the administration of the unconjugated antisense oligonucleotide (ASO), which shares the same nucleotide sequence but lacks the (GalNAc) moiety [see Description (11) ] , were evaluated. In a combined fertility and embryo-fetal development study in mice, the unconjugated ASO was administered to male and female mice by subcutaneous injection at doses of 10.5, 35, and 87.5 mg/kg/week prior to mating and through to the completion of organogenesis (gestation day 15). No adverse developmental outcomes occurred at doses up to 87.5 mg/kg/week (approximately 21-times the monthly maximum recommended human dose (MRHD) based on a body surface area (BSA) comparison of the unconjugated ASO).
In an embryo-fetal development study in pregnant rabbits, the unconjugated ASO was administered by subcutaneous injection at doses of 10.5, 21, and 52.5 mg/kg/week during the period of organogenesis (gestation days 6 to 18). No adverse developmental effects were observed at doses up to 21 mg/kg/week (approximately 20-times the monthly MRHD based on a BSA comparison of the unconjugated ASO). In a pre-/postnatal toxicity study in mice, the unconjugated ASO was administered at 10.5, 35, or 87.5 mg/kg/week during the period of organogenesis and continuing until weaning (gestation day 6 through lactation day 21).
Offspring body weights at 87.5 mg/kg/week (21-times the monthly MRHD based on BSA) were lower throughout their lives and were associated with slight delays in the attainment of morphological and developmental landmarks. No adverse effects on offspring were observed at 35 mg/kg/week (approximately 9-times the monthly MRHD based on a BSA comparison of the unconjugated ASO).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of TRYNGOLZA in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use No dose adjustment is recommended in patients aged 65 years and older [see Clinical Pharmacology (12.3) ] . In clinical trials, 243 patients treated with TRYNGOLZA were ≥65 years of age. No overall differences in safety or effectiveness of TRYNGOLZA have been observed between patients 65 years of age and older and younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Olezarsen is an ASO-GalNAc 3 conjugate that binds to apoC-III mRNA leading to mRNA degradation and resulting in a reduction of serum apoC-III protein. Reduction of apoC-III protein leads to increased clearance of plasma TG and very low-density lipoprotein (VLDL).
12.2Pharmacodynamics Fasting apoC-III Olezarsen decreased fasting apoC-III following administration of TRYNGOLZA 80 mg dosage every 4 weeks to patients with FCS [see Clinical Studies (14.1) ] . The placebo-corrected percent change in fasting apoC-III from baseline was -57% at 1 month, -69% at 3 months, -72% at 6 months, and -80% at 12 months. Olezarsen also decreased fasting apoC-III following administration of TRYNGOLZA 50 mg and 80 mg every 4 weeks in patients with sHTG [see Clinical Studies (14.2) ] .
The placebo-corrected percent change in fasting apoC-III from baseline in Trial 2 was -68% at Month 6 and -67% at Month 12 in patients treated with TRYNGOLZA 50 mg, and -77% at Month 6 and -72% at Month 12 in patients treated with TRYNGOLZA 80 mg. In Trial 3, the placebo-corrected percent change in fasting apoC-III from baseline was -57% at Month 6 and -53% at Month 12 in patients treated with TRYNGOLZA 50 mg, and -63% at Month 6 and -58% at Month 12 in patients treated with TRYNGOLZA 80 mg. Cardiac Electrophysiology At a dose 1.5-times the maximum approved recommended dosage, TRYNGOLZA does not prolong the QT interval to any clinically relevant extent.
12.3Pharmacokinetics Olezarsen steady-state geometric mean (geometric % coefficient of variation [geometric %CV]) maximum concentrations (C max ) is 659 (88.5%) ng/mL and area under the curve (AUC τ ) is 8,030 (83.7%) ng*h/mL at the approved recommended dosage in patients with FCS (80 mg per month); 157 (90%) ng/mL and 3,470 (104%) ng*h/mL, respectively, at 50 mg once monthly in patients with sHTG, and 251 (90%) ng/mL and 5,550 (104%) ng*h/mL, respectively, at 80 mg once monthly in patients with sHTG. Olezarsen C max and AUC increase dose-proportionally following single subcutaneous doses ranging from 10 to 120 mg (i.e., 0.13- to 1.5-times the approved recommended dose) in healthy volunteers.
No olezarsen accumulation occurs with repeat dosing. Absorption Olezarsen time to C max (T max ) is approximately 2 hours following subcutaneous administration. Distribution The population estimates for the apparent central volume of distribution is
96.1L and 127 L and the apparent peripheral volume of distribution is 3,920 L and 6,660 L, for patients with FCS and sHTG, respectively, for olezarsen. Olezarsen is greater than 99% bound to plasma proteins, in vitro . Olezarsen distributes primarily to the liver and kidney after subcutaneous dosing.
Elimination Olezarsen terminal elimination half-life is approximately 4 weeks. Metabolism Olezarsen is metabolized by endo- and exonucleases to short oligonucleotide fragments of varying sizes within the liver. Excretion Less than 1% of olezarsen administered dose is eliminated unchanged in urine within 24 hours.
Specific Populations No clinically significant differences in the pharmacokinetics of olezarsen were observed based on age (<65 to ≥75 years), body weight, sex, race (White, Black or African American, Asian, Japanese, American Indian or Alaska Native, Native Hawaiian or Pacific Islander), mild-to-moderate renal impairment (eGFR ≥30 to <90 mL/min) [CKD-EPI], mild hepatic impairment (total bilirubin ≤ULN and AST >ULN, or total bilirubin >1 to 1.5 x ULN and any AST, National Cancer Institute Organ Dysfunction Working Group criteria), or moderate hepatic impairment (Child-Pugh Class B score of 7 to 9).
The effect of severe renal impairment (eGFR<30 mL/min), end-stage renal disease, or severe hepatic impairment (total bilirubin >3x ULN with any AST) on olezarsen pharmacokinetics is unknown. Drug Interaction Studies In Vitro Studies CYP450 Enzymes: Olezarsen is not an inhibitor or inducer of CYP450 enzymes. Transporter Systems: Olezar… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Olezarsen is an ASO-GalNAc 3 conjugate that binds to apoC-III mRNA leading to mRNA degradation and resulting in a reduction of serum apoC-III protein. Reduction of apoC-III protein leads to increased clearance of plasma TG and very low-density lipoprotein (VLDL).
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied TRYNGOLZA injection is a sterile, preservative-free, clear, colorless to yellow solution supplied in a single-dose autoinjector. Each autoinjector of TRYNGOLZA is filled to deliver 0.8 mL of solution containing 50 mg or 80 mg of olezarsen. TRYNGOLZA is supplied as: Carton containing one 50 mg single-dose autoinjector: (NDC 71860-102-01). Carton containing one 80 mg single-dose autoinjector: (NDC 71860-101-01).
16.2Storage and Handling Store the TRYNGOLZA autoinjector in the refrigerator between 2°C and 8°C (36°F and 46°F) in the original carton. Once taken out of the refrigerator, the TRYNGOLZA autoinjector can be stored at room temperature between 15°C and 30°C (59°F and 86°F) in the original carton for up to 6 weeks. If not used within the 6 weeks stored at room temperature, discard TRYNGOLZA. Do not expose to heat. Protect from light.
16.1How Supplied TRYNGOLZA injection is a sterile, preservative-free, clear, colorless to yellow solution supplied in a single-dose autoinjector. Each autoinjector of TRYNGOLZA is filled to deliver 0.8 mL of solution containing 50 mg or 80 mg of olezarsen. TRYNGOLZA is supplied as: Carton containing one 50 mg single-dose autoinjector: (NDC 71860-102-01). Carton containing one 80 mg single-dose autoinjector: (NDC 71860-101-01).
📦 Storage and Handling ▾
16.2Storage and Handling Store the TRYNGOLZA autoinjector in the refrigerator between 2°C and 8°C (36°F and 46°F) in the original carton. Once taken out of the refrigerator, the TRYNGOLZA autoinjector can be stored at room temperature between 15°C and 30°C (59°F and 86°F) in the original carton for up to 6 weeks. If not used within the 6 weeks stored at room temperature, discard TRYNGOLZA. Do not expose to heat. Protect from light.
📋 Description ▾
11 DESCRIPTION Olezarsen is an ASO directed inhibitor of apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three GalNAc residues to enable delivery of the ASO to hepatocytes. TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer.
The molecular formula of olezarsen sodium is C 296 H 419 N 71 O 154 P 20 S 19 Na 20 and the molecular weight is 9124.48 daltons. The chemical name of olezarsen sodium is DNA, d(P-thio) ([2'- O -(2-methoxyethyl)] rA-[2'- O -(2-methoxyethyl)] rG-[2'- O -(2-methoxyethyl)] m5rC-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] m5rU-m5C-T-T-G-T-m5C-m5C-A-G-m5C-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] m5rU-[2'- O -(2-methoxyethyl)] rA-[2'- O -(2-methoxyethyl)]m5rU), 5'-[26-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20).
The structure of olezarsen sodium is presented below: TRYNGOLZA is a sterile, preservative-free solution for subcutaneous injection. Each single-dose autoinjector contains 50 mg olezarsen (equivalent to 53 mg of olezarsen sodium) in 0.8 mL of solution or 80 mg olezarsen (equivalent to 84 mg of olezarsen sodium) in 0.8 mL of solution. The solution also contains the following inactive ingredients: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate to maintain pH and provide tonicity, and water for injection.
The solution may include hydrochloric acid and/or sodium hydroxide for pH adjustment between 6.9 to 7.9. Each 50 mg dose of TRYNGOLZA injection contains 4 mg of phosphorous and 4 mg of sodium. Each 80 mg dose of TRYNGOLZA injection contains 6 mg of phosphorous and 5 mg of sodium.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Hypersensitivity Inform patients that serious hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgia, have been reported in patients treated with TRYNGOLZA. Advise patients on the signs and symptoms of hypersensitivity reactions and instruct them to stop taking TRYNGOLZA and seek medical advice promptly if such symptoms occur [see Warnings and Precautions (5.1) ] .
Liver Enzyme Abnormalities Inform patients that TRYNGOLZA may cause liver enzyme elevations. Advise patients to promptly report fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.2) ] . Adherence to Diet Advise patients to maintain a low-fat diet in conjunction with TRYNGOLZA.
Instruct patients with FCS to consume 20 g of fat or less per day [see Dosage and Administration (2) ] . Missed Dose Instruct patients to take TRYNGOLZA as prescribed. If a dose is missed, instruct patients to take it as soon as they remember.
Resume dosing at monthly intervals from the date of the most recently administered dose [see Dosage and Administration (2.2) ] .
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Olezarsen steady-state geometric mean (geometric % coefficient of variation [geometric %CV]) maximum concentrations (C max ) is 659 (88.5%) ng/mL and area under the curve (AUC τ ) is 8,030 (83.7%) ng*h/mL at the approved recommended dosage in patients with FCS (80 mg per month); 157 (90%) ng/mL and 3,470 (104%) ng*h/mL, respectively, at 50 mg once monthly in patients with sHTG, and 251 (90%) ng/mL and 5,550 (104%) ng*h/mL, respectively, at 80 mg once monthly in patients with sHTG. Olezarsen C max and AUC increase dose-proportionally following single subcutaneous doses ranging from 10 to 120 mg (i.e., 0.13- to 1.5-times the approved recommended dose) in healthy volunteers.
No olezarsen accumulation occurs with repeat dosing. Absorption Olezarsen time to C max (T max ) is approximately 2 hours following subcutaneous administration. Distribution The population estimates for the apparent central volume of distribution is
96.1L and 127 L and the apparent peripheral volume of distribution is 3,920 L and 6,660 L, for patients with FCS and sHTG, respectively, for olezarsen. Olezarsen is greater than 99% bound to plasma proteins, in vitro . Olezarsen distributes primarily to the liver and kidney after subcutaneous dosing.
Elimination Olezarsen terminal elimination half-life is approximately 4 weeks. Metabolism Olezarsen is metabolized by endo- and exonucleases to short oligonucleotide fragments of varying sizes within the liver. Excretion Less than 1% of olezarsen administered dose is eliminated unchanged in urine within 24 hours.
Specific Populations No clinically significant differences in the pharmacokinetics of olezarsen were observed based on age (<65 to ≥75 years), body weight, sex, race (White, Black or African American, Asian, Japanese, American Indian or Alaska Native, Native Hawaiian or Pacific Islander), mild-to-moderate renal impairment (eGFR ≥30 to <90 mL/min) [CKD-EPI], mild hepatic impairment (total bilirubin ≤ULN and AST >ULN, or total bilirubin >1 to 1.5 x ULN and any AST, National Cancer Institute Organ Dysfunction Working Group criteria), or moderate hepatic impairment (Child-Pugh Class B score of 7 to 9).
The effect of severe renal impairment (eGFR<30 mL/min), end-stage renal disease, or severe hepatic impairment (total bilirubin >3x ULN with any AST) on olezarsen pharmacokinetics is unknown. Drug Interaction Studies In Vitro Studies CYP450 Enzymes: Olezarsen is not an inhibitor or inducer of CYP450 enzymes. Transporter Systems: Olezarsen is not a substrate or inhibitor of OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2-K, BCRP, P-gp, and BSEP.
Protein Binding: Olezarsen does not displace warfarin and ibuprofen from plasma protein binding sites.
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics Fasting apoC-III Olezarsen decreased fasting apoC-III following administration of TRYNGOLZA 80 mg dosage every 4 weeks to patients with FCS [see Clinical Studies (14.1) ] . The placebo-corrected percent change in fasting apoC-III from baseline was -57% at 1 month, -69% at 3 months, -72% at 6 months, and -80% at 12 months. Olezarsen also decreased fasting apoC-III following administration of TRYNGOLZA 50 mg and 80 mg every 4 weeks in patients with sHTG [see Clinical Studies (14.2) ] .
The placebo-corrected percent change in fasting apoC-III from baseline in Trial 2 was -68% at Month 6 and -67% at Month 12 in patients treated with TRYNGOLZA 50 mg, and -77% at Month 6 and -72% at Month 12 in patients treated with TRYNGOLZA 80 mg. In Trial 3, the placebo-corrected percent change in fasting apoC-III from baseline was -57% at Month 6 and -53% at Month 12 in patients treated with TRYNGOLZA 50 mg, and -63% at Month 6 and -58% at Month 12 in patients treated with TRYNGOLZA 80 mg. Cardiac Electrophysiology At a dose 1.5-times the maximum approved recommended dosage, TRYNGOLZA does not prolong the QT interval to any clinically relevant extent.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Adult Patients with Familial Chylomicronemia Syndrome The efficacy of TRYNGOLZA was demonstrated in a randomized, placebo-controlled, double-blind clinical trial in adult patients with genetically identified FCS and fasting TG levels ≥880 mg/dL (Trial 1; NCT04568434 ). After a ≥4-week run-in period where patients continued to follow a low-fat diet with ≤20 grams fat per day, patients were randomly assigned to receive doses every 4 weeks of TRYNGOLZA 80 mg (n=22) or matching volume of placebo (n=23) via subcutaneous injection over a 53-week treatment period.
Patient demographic and baseline characteristics were generally similar across the treatment groups [see Adverse Reactions (6.1) ] . The proportion of patients with diabetes at enrollment was 32% in the TRYNGOLZA 80 mg group compared with 26% in the placebo group. Patients in the TRYNGOLZA 80 mg and placebo groups were treated with statins (27%), omega-3 fatty acids (42%), fibrates (49%), or other lipid-lowering therapies (13%) at study entry.
Seventy-one percent (71%) of patients in the TRYNGOLZA 80 mg and placebo groups combined had a history of documented acute pancreatitis in the prior 10 years. Mean (SD) and median fasting TG levels at baseline were 2,604 (1,364) mg/dL and 2,303 mg/dL, respectively (range of 334 to 6,898 mg/dL). The primary endpoint was percent change in fasting TG from baseline to Month 6 (average of Weeks 23, 25, and 27) compared to placebo.
The difference between TRYNGOLZA 80 mg group and the placebo group in percent change in fasting TG from baseline to Month 6 was -43% (95% CI: -74%, -11%; p=0.0084). For additional results see Table 3. Table 3.
Mean Baseline (BL) and Mean Percent (%) Changes from Baseline in Lipid/ Lipoprotein Parameters in Patients with FCS at Month 6 in Patients with FCS (Trial 1) Abbreviations: apoB = apolipoprotein B; non-HDL-C = non high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol. Note: Analyses results were based on an analysis of covariance model with treatment, the two randomization stratification factors, prior history of pancreatitis within 10 years prior to Screening (yes vs. no), previous treatment with the unconjugated ASO (yes vs. no) as the fixed effects and log-transformed Baseline value as a covariate.
Missing data was imputed using placebo washout imputation. The 95% CIs of treatment differences were calculated using a robust variance estimator. For TG and non-HDL, a test of residual normality did not indicate significant departure from normal distribution.
Parameter (mg/dL) TRYNGOLZA 80 mg N=22 Placebo N=23 TRYNGOLZA 80 mg vs. Placebo BL % change Month 6 BL % change Month 6 Treatment Difference % change (95% CI) at Month 6 TG 2613 -30 2596 +12 -43 Reached statistical significance (p value <0.05). (-74, -11) Non-HDL-C 263 -18 271 +6 -23 (-45, -2) LDL-C 23 +64 17 +9 +55 Mean LDL-C levels increased but remained within normal range (i.e., <70 mg/dL for 74% of patients treated with TRYNGOLZA).
(1, 109) Total ApoB 58 +20 60 +9 +12 (-13, 36) ApoB-48 12 -51 14 +25 -76 (-150, -2) Median percent change from baseline (Figure 1) and median absolute TG values (Figure 2) over time demonstrated a consistent lowering effect during the 12-month treatment period. Figure 1. Percent Change in Fasting TG (mg/dL) Over Time in Patients with FCS (Trial 1) Figure 2.
Fasting TG (mg/dL) Over Time in Patients with FCS (Trial 1) Over the 12-month treatment period, the numerical incidence of acute pancreatitis in patients treated with TRYNGOLZA 80 mg was lower compared with placebo [1 (5%) patient in the TRYNGOLZA 80 mg group compared with 7 (30%) patients in the placebo group]; all of these patients had a prior history of pancreatitis within 10 years prior to screening. image1 image2
14.2Adult Patients with Severe Hypertriglyceridemia The efficacy of TRYNGOLZA was demonstrated in two randomized, double-blind, placebo-controlled trials (Trial 2, NCT05079919 and Trial 3, NCT05552326… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No long-term carcinogenicity studies were conducted with olezarsen in animals. However, the unconjugated antisense oligonucleotide (ASO) lacking GalNAc was administered weekly in mice and rats at subcutaneous doses of 0, 6, 25 and 40 mg/kg/week (along with a mouse-specific surrogate ASO at 25 mg/kg/week) and 0, 0.2, 1 and 5 mg/kg/week, respectively, for 2 years. In male mice, there were statistically significant increases in the incidences of hepatocellular adenomas and carcinomas at ≥25 mg/kg/week and hemangiomas and hemangiosarcomas at all doses.
In female mice, there were statistically significant increases in the incidences of histiocytic sarcomas at all doses (including the mouse-specific surrogate) and pituitary gland adenomas at 25 mg/kg/week. In rats, the incidence of malignant fibrous histiocytoma at the injection site was increased in both sexes at doses ≥1 mg/kg/week. These tumors are considered a response to chronic tissue irritation and inflammation caused by repeated subcutaneous injection.
The clinical significance of these findings is uncertain. Mutagenesis Olezarsen was negative for genotoxicity in vitro (bacterial reverse mutation assay and chromosome aberration assay in Chinese hamster lung cells) and in vivo (mouse bone marrow micronucleus assay). Impairment of Fertility Olezarsen was administered at doses of 0, 5, 10, or 20 mg/kg given every other week to male and female mice prior to mating, followed by every other day dosing after mating and until gestation day 6 in females.
There was no effect on fertility in mice administered olezarsen at doses up to 20 mg/kg (approximately 2-times the monthly maximum recommended human dose based on body surface area).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis No long-term carcinogenicity studies were conducted with olezarsen in animals. However, the unconjugated antisense oligonucleotide (ASO) lacking GalNAc was administered weekly in mice and rats at subcutaneous doses of 0, 6, 25 and 40 mg/kg/week (along with a mouse-specific surrogate ASO at 25 mg/kg/week) and 0, 0.2, 1 and 5 mg/kg/week, respectively, for 2 years. In male mice, there were statistically significant increases in the incidences of hepatocellular adenomas and carcinomas at ≥25 mg/kg/week and hemangiomas and hemangiosarcomas at all doses.
In female mice, there were statistically significant increases in the incidences of histiocytic sarcomas at all doses (including the mouse-specific surrogate) and pituitary gland adenomas at 25 mg/kg/week. In rats, the incidence of malignant fibrous histiocytoma at the injection site was increased in both sexes at doses ≥1 mg/kg/week. These tumors are considered a response to chronic tissue irritation and inflammation caused by repeated subcutaneous injection.
The clinical significance of these findings is uncertain. Mutagenesis Olezarsen was negative for genotoxicity in vitro (bacterial reverse mutation assay and chromosome aberration assay in Chinese hamster lung cells) and in vivo (mouse bone marrow micronucleus assay). Impairment of Fertility Olezarsen was administered at doses of 0, 5, 10, or 20 mg/kg given every other week to male and female mice prior to mating, followed by every other day dosing after mating and until gestation day 6 in females.
There was no effect on fertility in mice administered olezarsen at doses up to 20 mg/kg (approximately 2-times the monthly maximum recommended human dose based on body surface area).
📄 Patient Package Insert ▾
PATIENT INFORMATION TRYNGOLZA ® [trin-GOLE-zah] (olezarsen) injection, for subcutaneous use This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 06/2026 What is TRYNGOLZA? TRYNGOLZA is a prescription medicine used along with diet to: Reduce triglycerides (fat in the blood) in the treatment of adults with a condition that keeps the body from breaking down fats called familial chylomicronemia syndrome (FCS).
Reduce triglycerides and reduce the risk of acute inflammation of your pancreas (pancreatitis) in the treatment of adults with a condition marked by very high levels of triglycerides in the blood called severe hypertriglyceridemia (sHTG). It is not known if TRYNGOLZA is safe and effective in children. Do not use TRYNGOLZA if: you have had a serious allergic reaction to olezarsen or any of the ingredients in TRYNGOLZA.
See the end of this Patient Information for a complete list of ingredients. Before using TRYNGOLZA, tell your healthcare provider about all of your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if TRYNGOLZA can harm your unborn baby.
Tell your healthcare provider if you become pregnant while using TRYNGOLZA. are breastfeeding or plan to breastfeed. It is not known if TRYNGOLZA passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby while using TRYNGOLZA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use TRYNGOLZA? Read the detailed Instructions for Use that comes with your TRYNGOLZA single-dose autoinjector. Your healthcare provider will show you or your caregiver how to inject TRYNGOLZA the first time.
TRYNGOLZA is injected under your skin (subcutaneous use) in your stomach area (abdomen) or the front of your upper legs (thighs). Only a healthcare provider or caregiver may give you an injection in the back of your upper arm. TRYNGOLZA should be injected 1 time each month.
If you miss a dose, take the missed dose as soon as possible. Then inject TRYNGOLZA 1 month from the date of your last dose to get back on a monthly dosing schedule. If you have questions about your dosing schedule, ask your healthcare provider.
Stay on your low-fat diet (less than 20 grams of fat each day if you have FCS) while using TRYNGOLZA. What are the possible side effects of TRYNGOLZA? Allergic reactions : TRYNGOLZA can cause side effects including allergic reactions that may be serious.
Allergic reactions can include redness of the skin, red itchy bumps (hives), swelling of the face, chills or trouble breathing. Stop taking TRYNGOLZA and call your healthcare provider or get emergency help right away if you have any of these symptoms. Liver problems : TRYNGOLZA can cause increases in liver enzymes and fat stored inside the liver.
Your healthcare provider may do liver tests before you start taking TRYNGOLZA or if there is an increase in your dose. Tell your healthcare provider right away if you have the following symptoms of liver problems: feeling tired or weak loss of appetite right upper stomach discomfort dark colored urine yellowing of the skin and eyes The most common side effects of TRYNGOLZA in people with FCS include: injection site reactions (such as redness, itching, rash, or pain at the injection site) decreased platelet count (blood cells that help to clot blood) joint pain or stiffness The most common side effects of TRYNGOLZA in people with sHTG include: injection site reactions (such as redness, itching, rash, or pain at the injection site) increased liver enzymes These are not all the possible side effects of TRYNGOLZA.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away… [Excerpted — this section continues on DailyMed.]
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE TRYNGOLZA ® [trin-GOLE-zah] (olezarsen) injection, for subcutaneous use Single-dose autoinjector 50 mg/0.8 mL and 80 mg/0.8 mL This Instructions for Use has been approved by the U.S. Food and Drug Administration Revised: 06/2026 This Instructions for Use contains information on how to inject TRYNGOLZA ® using the autoinjector. Read this Instructions for Use before you start using your TRYNGOLZA autoinjector and each time you get a refill.
There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Your healthcare provider should show you or your caregiver how to use the TRYNGOLZA autoinjector the right way.
If you or your caregiver have any questions, talk to your healthcare provider. Important information: TRYNGOLZA is injected under the skin (subcutaneous use) only. Each autoinjector contains 1 single-dose and can only be used 1 time.
Do not remove the clear cap until you are ready to inject TRYNGOLZA (See Step 5). Do not share your autoinjector with anyone. Do not use if the autoinjector appears damaged.
Storage information: Store the autoinjector in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton. TRYNGOLZA can also be stored at room temperature between 59°F to 86°F (15°C to 30°C) in the original carton for up to 6 weeks. Do not let TRYNGOLZA reach temperatures above 86°F (30°C).
Throw away the TRYNGOLZA autoinjector if kept at room temperature longer than 6 weeks . Do not expose the autoinjector to heat. Protect from light.
Keep the autoinjector in the carton until ready to use. Do not store the autoinjector with the clear cap removed. Keep TRYNGOLZA and all medicine out of the reach of children.
Parts of your TRYNGOLZA autoinjector Single-dose autoinjector Other supplies (not included) Alcohol wipe Sharps container Cotton ball or gauze Small bandage Preparing to inject TRYNGOLZA Step 1 Remove from the refrigerator a) Remove the autoinjector from the refrigerator. b) Keep the autoinjector in the original carton and let the autoinjector come to room temperature for 30 minutes before injecting. Do not try to speed up the warming process using other heat sources, such as a microwave or hot water. Step 2 Check the medicine a) Check the expiration (EXP) date. b) Check the medicine through the viewing window.
The TRYNGOLZA medicine should be clear and colorless to yellow. There should be no particles. It is normal to see air bubbles in the solution.
Do not use the autoinjector if the: clear cap is missing or not attached. expiration (EXP) date has passed. medicine looks cloudy, discolored, or has particles. autoinjector appears damaged. Step 3 Choose the injection site a) Choose an injection site on the stomach or the front of the thigh. b) Only your healthcare provider or caregivers may choose the back of upper arm. Do not inject: within 2 inches (5 cm) of the belly button (navel). into skin that is bruised, tender, red, or hard. into scars or damaged skin.
Step 4 Wash hands and clean the injection site a) Wash your hands with soap and water. b) Clean the injection site with an alcohol wipe in a circular motion. Let the skin air dry. Do not touch the cleaned skin before injecting.
Injecting TRYNGOLZA Step 5 Remove and throw away the clear cap a) Hold the autoinjector by the middle with the clear cap facing away from you. b) Remove the clear cap by pulling it straight off. Do not twist it off. The needle is inside the orange needle shield. c) Throw away the clear cap in the trash or sharps container.
Do not remove the clear cap until right before you inject. Do not recap the autoinjector. Do not push the orange needle shield against the hand or finger.
Step 6 Begin injection a) Hold the autoinjector in 1 hand. Place the orange needle shield at a 90-degree angle against your skin. Make sure you can see the viewing window. b) Push firmly and hold the autoinjector straight against the skin.
Yo… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Indications and Usage ( 1 ) 06/2026 Dosage and Administration, Recommended Dosage ( 2.1 ) 06/2026 Warnings and Precautions Liver Enzyme Abnormalities ( 5.2 ) 06/2026
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Autoinjector Carton Tryngolza ® (olezarsen) injection 80 mg/0.8 mL For subcutaneous use One single-dose autoinjector Each TRYNGOLZA autoinjector contains 80 mg olezarsen (equivalent to 84 mg olezarsen sodium) in 0.8 mL of solution, single-dose. IONIS ® NDC 71860-101-01 Rx Only Discard after ____ / ____ / ____ PRINCIPAL DISPLAY PANEL - 80 mg/0.8 mL Autoinjector Carton
PRINCIPAL DISPLAY PANEL - 50 mg/0.8 mL Autoinjector Carton Tryngolza ® (olezarsen) injection 50 mg/0.8 mL For subcutaneous use One single-dose autoinjector Each TRYNGOLZA autoinjector contains 50 mg olezarsen (equivalent to 53 mg olezarsen sodium) in 0.8 mL of solution, single-dose. IONIS ® NDC 71860-102-01 Rx Only Discard after ____ / ____ / ____ PRINCIPAL DISPLAY PANEL - 50 mg/0.8 mL Autoinjector Carton
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